@Ipsum FDA process doesn't involve much too-ing and fro-ing on safety, efficacy, stability, manufacturing elements of the submission. However, small adjustments on labelling and patient information - which are easily addressed - are commonly discussed immedaitely ahead of the final decision.

The last rejection was more fundamental, because the decision related to instructions for patient use. These needed to be corrected and validated in a human factors study. It was impossible to address them purely via dialogue. However, fine details of labelling and patient information can easily be addressed, and this is not uncommon.

What IS uncommon (or less common) - in my experience, is for the company to make a price sensitive announcement about these discussions, so close to the approval.

To me, that might indicate that management are nervous about approval, and want to be able to demonstrate that they kept shareholders fully informed. There is certainly no other benefit (from my perspective) in today's announcement.

So, I am on the edge of my seat with this one. I have it 90% CoS,.... but there is the 10%.

BTW, I haven't read the full release, just your headlines, as I am doing other things today. I certainly hope a further delay (or rejection) isn't on the cards. However, the point of my post is to reassure that final dialogue on labelling/PIL is not unusual.